Off–label long acting injectable antipsychotics in real–world clinical practice: a cross-sectional analysis of prescriptive patterns from the STAR Network DEPOT study

• Published in: BMC psychiatry Vol. 22; no. 1; pp. 1 - 442
• Main Authors: D’Agostino, Armando, Aguglia, Andrea, Barbui, Corrado, Bartoli, Francesco, Carrà, Giuseppe, Cavallotti, Simone, Chirico, Margherita, Ostinelli, Edoardo G., Zangani, Caroline, Martinotti, Giovanni, Ostuzzi, Giovanni, Nosè, Michela, Purgato, Marianna, Turrini, Giulia, Mazzi, Maria Angela, Papola, Davide, Gastaldon, Chiara, Terlizzi, Samira, Bertolini, Federico, Piccoli, Alberto, Ruggeri, Mirella, De Fazio, Pasquale, Magliocco, Fabio, Caroleo, Mariarita, Raffaele, Gaetano, Ostinelli, Edoardo Giuseppe, Bergamelli, Emilio, Lucii, Claudio, Bolognesi, Simone, Debolini, Sara, Pierantozzi, Elisa, Fargnoli, Francesco, Del Zanna, Maria, Giannini, Alessandra, Luccarelli, Livia, De Capua, Alberto, Annese, Pasqua Maria, Cerretini, Massimiliano, Tozzi, Fiorella, Magnani, Nadia, Cardamone, Giuseppe, Bardicchia, Francesco, Facchi, Edvige, Soscia, Federica, Zotos, Spyridon, Biancosino, Bruno, Zonta, Filippo, Pompei, Francesco, Callegari, Camilla, Zizolfi, Daniele, Poloni, Nicola, Ielmini, Marta, Caselli, Ivano, Giana, Edoardo, Buzzi, Aldo, Diurni, Marcello, Milano, Anna, Sani, Emanuele, Calzolari, Roberta, Bortolaso, Paola, Piccinelli, Marco, Cazzamalli, Sara, Alberini, Gabrio, Piantanida, Silvia, Costantini, Chiara, Paronelli, Chiara, Di Caro, Angela, Moretti, Valentina, Gozzi, Mauro, D’Ippolito, Chiara, Barbanti, Silva Veronica, Alessandro, Papalini, Corbo, Mariangela, Campese, Ornella, Fiori, Federica, Lorusso, Marco, Di Capro, Lucia, Viceconte, Daniela, Mancini, Valerio, Suraniti, Francesco, Signorelli, Maria Salvina, Rossi, Eugenio, Lupoli, Pasqualino, Menchetti, Marco, Terzi, Laura, Boso, Marianna, Risaro, Paolo, De Paoli, Giuseppe, Catania, Cristina, Tarricone, Ilaria, Caretto, Valentina, Storbini, Viviana, Emiliani, Roberta, Balzarro, Beatrice, Tabacchi, Tommaso, Nava, Roberto, Bono, Adele, Provenzi, Milena, Brambilla, Giulia, Aspesi, Flora
• Format: Journal Article
• Language: English
• Published: London BioMed Central Ltd 30-06-2022; BioMed Central; BMC
• Subjects: Age; Alcohol; Analysis; Antipsychotic drugs; Antipsychotics; Bipolar disorder; Clinical medicine; Cross-sectional studies; Dosage and administration; FDA approval; Licenses; Long-acting injectable antipsychotics; Off-label; Off-label prescribing; Patients; Personality; Personality disorder; Personality disorders; Prescriptions; Psychiatry; Psychotropic drugs; Schizophrenia; Sociodemographics; Variables; Italy
• ISSN: 1471-244X; 1471-244X
• DOI: 10.1186/s12888-022-04071-2

Introduction Information on the off-label use of Long-Acting Injectable (LAI) antipsychotics in the real world is lacking. In this study, we aimed to identify the sociodemographic and clinical features of patients treated with on- vs off-label LAIs and predictors of off-label First- or Second-Generation Antipsychotic (FGA vs. SGA) LAI choice in everyday clinical practice. Method In a naturalistic national cohort of 449 patients who initiated LAI treatment in the STAR Network Depot Study, two groups were identified based on off- or on-label prescriptions. A multivariate logistic regression analysis was used to test several clinically relevant variables and identify those associated with the choice of FGA vs SGA prescription in the off-label group. Results SGA LAIs were more commonly prescribed in everyday practice, without significant differences in their on- and off-label use. Approximately 1 in 4 patients received an off-label prescription. In the off-label group, the most frequent diagnoses were bipolar disorder (67.5%) or any personality disorder (23.7%). FGA vs SGA LAI choice was significantly associated with BPRS thought disorder (OR = 1.22, CI95% 1.04 to 1.43, p = 0.015) and hostility/suspiciousness (OR = 0.83, CI95% 0.71 to 0.97, p = 0.017) dimensions. The likelihood of receiving an SGA LAI grew steadily with the increase of the BPRS thought disturbance score. Conversely, a preference towards prescribing an FGA was observed with higher scores at the BPRS hostility/suspiciousness subscale. Conclusion Our study is the first to identify predictors of FGA vs SGA choice in patients treated with off-label LAI antipsychotics. Demographic characteristics, i.e. age, sex, and substance/alcohol use co-morbidities did not appear to influence the choice towards FGAs or SGAs. Despite a lack of evidence, clinicians tend to favour FGA over SGA LAIs in bipolar or personality disorder patients with relevant hostility. Further research is needed to evaluate treatment adherence and clinical effectiveness of these prescriptive patterns. Keywords: Long-acting injectable antipsychotics, Schizophrenia, Bipolar disorder, Personality disorder, Off-label